MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA NEONATAL SKIN TEMPERATURE SENSOR; WARMER, INFANT RADIANT

Model Number	HNICU-37
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call (b)(4)) was received indicating that a neonatal skin temperature sensor (part hnicu-37, lot 53055099) was being used with a warmer when the warmer alarmed.The warmer indicated the neonate's temperature was low when it was in fact normal or high.The warmer was found to be working properly when serviced.The investigation is ongoing.This report will be updated when new or critical information is available.
Event or Problem Description
A warmer alarmed, notifying the baby's temperature registered as low.However, the temperature was normal or high, and the warmer continued to increase temperature.The warmer was checked by biomed and serviced by ge.It was confirmed the warmer was functioning as it should.
Additional Manufacturer Narrative
Root cause: no root cause was identified.Production records were reviewed with no issues found, and the returned samples were functionally tested and found to be within product specification.Corrective action: a corrective action has not been taken due to the root cause determination.Investigation summary: an internal complaint (b)(4) was received indicating that a neonatal skin temperature sensor (part hnicu-37, lot 53055099) was being used with a warmer when the warmer alarmed.The warmer indicated the neonate's temperature was low when it was in fact normal or high.The warmer was found to be working properly when serviced.Four samples were returned and functionally tested.All results were found to be within specification.No issues were identified.The device history record for the reported lot number was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.The sub-assembly work orders also were reviewed with no issues found.Product in process was inspected.A total of 80 samples were tested.All results were passing.A corrective and preventive action investigation has been opened to further investigate this issue.This report will be updated at the conclusion of the capa investigation.
Event or Problem Description
A warmer alarmed, notifying the baby's temperature registered as low.However, the temperature was normal or high, and the warmer continued to increase temperature.The warmer was checked by biomed and serviced by ge.It was confirmed the warmer was functioning as it should.

• Brand Name: NEONATAL SKIN TEMPERATURE SENSOR
• Common Device Name: WARMER, INFANT RADIANT
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA; global park; box 180-3006, 602 parkway; la aurora, heredia, heredia 146 ; CS 146
• MDR Report Key: 11342128
• Report Number: 9613793-2021-00002
• Device Sequence Number: 5036651
• Product Code: FMT
• UDI-Device Identifier: 00749756671361
• UDI-Public: 00749756671361
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K200319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HNICU-37
• Device Lot Number: 53055099
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1